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Thursday, December 10 2020 - 02:04
New Global Pooled Analysis Supports Clinical Utility of Circulating Tumor Cell Count for Early Monitoring of Metastatic Breast Cancer
BOLOGNA, Italy and HUNTINGDON VALLEY, Pa., December 9, 2020, /PRNewswire-AsiaNet/--

Menarini Silicon Biosystems [ ], a pioneer of 
liquid biopsy technology, today announced the results of a pooled analysis of 
14 clinical trials on the relevance of circulating tumor cell (CTC) count to 
predict both disease prognosis and treatment efficacy in metastatic breast 
cancer (MBC). This global study, based on 4 079 cases across all advanced 
breast cancer subtypes, is the largest pooled analysis to-date on the role of 
serial CTC count in the MBC setting. It included individual patient data and 
was selected for an oral presentation at the 2020 San Antonio Breast Cancer 

The analysis was led by Minetta C. Liu, MD 
[ ], 
Professor and Research Chair for the Department of Oncology and Consultant in 
the Department of Laboratory Medicine & Pathology at Mayo Clinic in Rochester, 
Minnesota, USA and Prof. Prof, Dr med Wolfgang Janni 
-of-obstetrics-and-gynecology.html ], Professor of Obstetrics, Adult and 
Pediatric Gynecology of the University Hospital Ulm, Germany. According to Dr. 
Liu, "This pooled analysis represents an international collaboration including 
an unprecedented number of multi-institutional clinical trials conducted across 
Asia, Europe, and North America. Colleagues kindly provided de-identified, 
individual patient level data from prospective clinical studies published in 
the peer-reviewed literature to generate a dataset of over 4000 participants. 
This statistical power allowed us to achieve our main objective – namely, to 
further define and validate the role of CTC enumeration for early monitoring of 
disease status in patients with metastatic breast cancer, irrespective of 
subtypes defined by hormone receptor and HER2 status." 

Data from this pooled analysis were gathered at baseline and then at a median 
of 29 days after treatment initiation. Detection, capture, isolation and 
phenotyping of tumor cells circulating in the blood in all patients was carried 
out with Menarini Silicon Biosystems' CELLSEARCH(R) CTC System. Results were 
determined by commonly used log rank and Cox regressions tests. The focus of 
these statistical analyses was on the association between serial CTC 
enumeration results and overall survival (OS) in the full patient cohort and 
defined subgroups. Subgroups included patients with hormone receptor positive, 
HER2 type and triple negative MBC as well patients whose breast cancer type was 
not specified. The conclusion across all groups is that patients whose CTC 
status is negative, both at baseline and follow-up, namely the reference group, 
have a median OS rate of 47.05 months compared to 17.87 months for those with a 
positive CTC status at both check points (p-value <0.0001). The importance of 
conducting follow-up analyses of patient CTCs is underlined by the data from 
all subgroups because they indicate that patients, whose CTC status went from 
positive to negative, had an OS of 32.2 months (HR 0.49, p-value <0.0001) an 
almost two-fold increase in the OS of patients whose CTC status remained 

"With the efficacy of novel therapies increasingly linked to the biological 
characteristics of a given tumor and the urgent need to continue to improve 
clinical interventions in the metastatic setting, this study strongly supports 
the potential of early CTC monitoring in all subtypes of MBC to optimize 
individual patient management along the treatment pathway and thereby improve 
patient outcomes," further commented Prof. Dr med Wolfgang Janni.

For Fabio Piazzalunga, President and CEO of Menarini Silicon Biosystems: "The 
results of this large and robust pooled analysis represent not only a major 
contribution to the expanding body of evidence aimed at validating the role of 
repeat CTC counts to optimize clinical interventions for the more difficult to 
treat MBC, they are also a testimony to the importance of developing more 
sophisticated prognostic/predictive approaches alongside new targeted therapies 
to reach the ultimate goal of improving both patient outcome and quality of 
life." As the pioneer in liquid biopsies, Menarini Silicon Biosystems is 
committed to developing its technology to help physicians identify appropriate 
treatment strategies in the challenging environment of heterogenous advanced 
breast cancers and growing number of therapeutic options from which to choose.


CELLSEARCH is the first and only clinically validated blood test cleared by the 
U.S. Food & Drug Administration (FDA) for detecting and counting CTCs to aid 
physicians in managing patients with metastatic breast, prostate, and 
colorectal cancers when used in conjunction with other clinical methods of 
monitoring. The test is also approved by the China National Medical Products 
Administration (NMPA) for use in monitoring patients with Metastatic Breast 
Cancer. The CELLSEARCH System [ ] is the most 
extensively studied CTC technology, with research published in more than 650 
peer-reviewed publications.

For more information on the full intended use and limitations of the CELLSEARCH 
system, please refer to the Instructions for Use at

About Menarini Silicon Biosystems

Menarini Silicon Biosystems offers unique rare cell technologies and solutions 
that provide clinical researchers with access to unparalleled resolution in the 
study of cells and their molecular characterization.

Menarini Silicon Biosystems [ ], based in 
Bologna, Italy, and Huntingdon Valley, Pa., U.S., is a wholly owned subsidiary 
of the Menarini Group, a multinational pharmaceutical, biotechnology and 
diagnostics company headquartered in Florence, Italy, with more than 17,000 
employees in 140 countries.

Contact: Linda Pavy - 

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SOURCE: Menarini Silicon Biosystems